The 21st Century Cures Act

[quietdynamics]

The 21st Century Cures Act passed in the House and will go to the Senate.
Often in posts we with SJS ask where/when will we have new treatments, sometimes lament the lag time of trials.

While the Act will will "fast track" drugs is that really the best route?

Reading some of the pro and con article regarding the Act, looking for information as it pertains to 'off-label', stem cell, insurance, I came upon information re: clinical trials. 
- Waiver of Informed Consent for Minimal Risk (Section 2263)  Center column p. 27 of article.
- HHS to amend HIPPS Rules Act to...     end of right column pg. 27 of article
- Inclusion of infusion biological products in DME payment methodology               second bullet center column pg. 28.

*This article is on a phara site and does not allow copy and paste. It does have a lot of information, not in media articles. http://www.pharmavoice.com/wp-content/uploads/PV1115_21stCenturyCuresAct_WM.pdf?tracker_id=1480602599

Something to be aware of and hopefully a help to us and others.

Assessing the Gold Standard — Lessons from the History of RCTs  (RCT, Randonized Control Trials) Laura E. Bothwell, Ph.D., Jeremy A. Greene, M.D., Ph.D., Scott H. Podolsky, M.D., and David S. Jones, M.D., Ph.D.
N Engl J Med 2016; 374:2175-2181June 2, 2016DOI: 10.1056/NEJMms1604593   http://www.nejm.org/doi/full/10.1056/NEJMms1604593

[SjoGirl]

Thanks the Autoimmune and Related Diseases Association is pushing folks to support the Act, but I heard a piece on NPR that made me wonder if it goes too far and might lead to harm being caused. I do understand the desire for cures and treatments, but also believe that we may have been spared some horrible issues as a result of erring on the side of caution.